Clinical trial · Interventional
Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients
Development and Preliminary Evaluation of an Evidence-based Somatic Acupressure Protocol for the Self-management of Symptom Cluster of Fatigue, Insomnia and Depression in Breast Cancer Patients
NCT04118140CI-TRIAL-00059791completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Using a robust research method following the MRC Framework, the proposed study will develop and test an evidence-based complementary health intervention to help breast cancer patients manage the fatigue-sleep disturbance-depression symptom cluster.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sham acupressure | Other | — | UNRESOLVED |
| Somatic Acupressure | Other | — | UNRESOLVED |
| Usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- True SA (Somatic Acupressure ) group
- description
- Receiving true somatic acupressure+usual care
- interventionNames
- Other: Somatic Acupressure
- Other: Usual care
- type
- SHAM_COMPARATOR
- label
- Sham SA group
- description
- Receiving sham somatic acupressure+usual care
- interventionNames
- Other: Sham acupressure
- Other: Usual care
- type
- OTHER
- label
- Usual care group
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. BC stage I to IIIa; 2. have experienced at least a moderate level of the FSD symptom cluster, with a score of 4 or above on a 10-point numeric rating scale, from "0 (no symptom)" to "10 (worst symptom)", for each symptom during the past one month; 3. have completed adjuvant chemotherapy for at least one month and up to three years; 4. have not scheduled chemotherapy and radiotherapy during the whole study period; 5. willing to participate in the RCT and provide written informed consent. Exclusion criteria: 1. presently taking pharmaceutical agents to treat fatigue, sleep disturbance or depression, such as antidepressant medications, psychostimulants, or hypnotics; 2. extremely weak and/or have cognitive impairment which make them unable (or difficult) to follow the study procedures and instructions; 3. having the experience of any types of SAS treatment during the past six months; 4. presently participating in any other research projects.
References
Publications (1)
- DERIVEDWang T, Tan JB, Liu XL, Zheng SL, Zhao I, Eliseeva S, Polotan MJ, Cheng HL, Huang HQ. Implementing an evidence-based somatic acupressure intervention in breast cancer survivors with the symptom cluster of fatigue, sleep disturbance and depression: study protocol of a phase II randomised controlled trial. BMJ Open. 2022 Jan 20;12(1):e054597. doi: 10.1136/bmjopen-2021-054597. PMID 35058263